BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROTEK CPR MICROMASK

    MDR report key: 1728350 · Received June 15, 2010

    Report

    Report Number
    8043817-2010-00002
    Event Type
    Death
    Date Received
    June 15, 2010
    Report Date
    June 15, 2010
    Manufacturer
    MICROTEK DOMINICA, S.A.
    Product Code
    CBP
    PMA / PMN Number
    K950769
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND WAS VISUALLY INSPECTED, PHOTOGRAPHED, AND SENT TO AN INDEPENDENT LABORATORY FOR PHYSICAL EVALUATION. RESULTS OF THESE TESTS HAVE NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF THE TEST REPORT FROM THE CONTRACTED LABORATORY.

    Description of Event or Problem · 1

    (B) (6) WITH (B) (6) AMBULANCE SERVICE WAS DISPATCHED TO ASSIST A (B) (6), FEMALE, IN CARDIAC ARREST. (B) (6) REQUESTED ASSISTANCE FROM THE FIRE CHIEF, WHO LIVED ACROSS THE STREET FROM THE LOCATION. THE FIRE CHIEF HAD THE MICROMASK IN HIS POSSESSION AND USED THE MASK ALONG WITH COMPRESSION (CPR) TO ATTEMPT TO REVIVE THE PATIENT. THE FIRE CHIEF PERFORMED CPR FOR 4 MINUTES PRIOR TO (B) (6) ARRIVING ON THE SCENE. THE FIRE CHIEF CLAIMED THAT AIR WOULD NOT FLOW THROUGH THE MASK. THIS WAS CONFIRMED BY (B) (6). COMPRESSIONS CONTINUED WHILE THE PATIENT WAS TRANSFERRED TO THE HOSPITAL. WHILE AT THE HOSPITAL, CARDIAC RHYTHM WAS DETECTED, HOWEVER, THE PATIENT EXPIRED. CAUSE OF DEATH WAS MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTEK CPR MICROMASK CPR MICROMASK (VALVE, NO-REBREATHING) CBP MICROTEK DOMINICA, S.A. 73-450 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death